País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
rabeprazole sodium, Quantity: 10 mg
Amneal Pharma Australia Pty Ltd
Rabeprazole sodium
Tablet, enteric coated
Excipient Ingredients: hyprolose; diacetylated monoglycerides; crospovidone; magnesium stearate; purified talc; hypromellose phthalate; ethylcellulose; light magnesium oxide; mannitol; titanium dioxide; heavy magnesium oxide
Oral
90, 30
(S4) Prescription Only Medicine
Indicated for: ,? Treatment and prevention of relapse of gastro-oesophageal reflux disease ,? Symptomatic treatment of gastro-oesophageal reflux disease ,? Treatment of duodenal ulcers ,? Treatment of gastric ulcers. ,Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. ,Also indicated, in combination with clarithromycin and amoxycillin, for: ,? Eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis ,? Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.
Visual Identification: Round, white, biconvex enteric-coated tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2012-04-05
_Rabeprazole AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 92.AN.M.1.0 _ _ _ _ _ _Page 1 _ RABEPRAZOLE AN TABLETS _Rabeprazole sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rabeprazole AN. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Rabeprazole AN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT RABEPRAZOLE AN IS USED FOR The name of your medicine is Rabeprazole AN. It contains the active ingredient rabeprazole sodium. Rabeprazole is used to treat - Reflux oesophagitis - Peptic ulcers - Chronic Gastritis _Reflux Oesophagitis: _ Rabeprazole AN is used to treat reflux oesophagitis or reflux disease. This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Rabeprazole AN is also used to help stop reflux oesophagitis from coming back or relapsing _Peptic Ulcers _ Rabeprazole AN is used to treat peptic ulcers. Depending on the position of the ulcer, it is called a gastric ulcer or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. The ulcers can be caused by too much acid being made in the stomach. Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxycillin) for you. When Rabeprazole AN is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal. _Chronic Gastritis _ The pr Leer el documento completo
1 AUSTRALIAN PRODUCT INFORMATION – RABEPRAZOLE AN (RABEPRAZOLE SODIUM) TABLETS 1 NAME OF THE MEDICINE rabeprazole sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RABEPRAZOLE AN is available as enteric coated tablets containing 10 mg rabeprazole sodium (equivalent to 9.42 mg rabeprazole) or 20 mg rabeprazole sodium (equivalent to 18.85 mg rabeprazole). For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM RABEPRAZOLE AN 10 mg tablets are round, white, biconvex enteric-coated tablets. RABEPRAZOLE AN 20 mg tablets are round, yellow, biconvex enteric-coated tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS RABEPRAZOLE AN is indicated for: • Treatment and prevention of relapse of gastro-oesophageal reflux disease • Symptomatic treatment of gastro-oesophageal reflux disease • Treatment of duodenal ulcers • Treatment of gastric ulcers. Patients whose gastric and duodenal ulceration is not associated with ingestion of non- steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. RABEPRAZOLE AN is also indicated, in combination with clarithromycin and amoxycillin, for: • Eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic 2 gastritis • Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers. 4.2 D OSE AND METHOD OF ADMINISTRATION RABEPRAZOLE AN tablets should not be chewed or crushed, but should be swallowed whole. RABEPRAZOLE AN tablets should be taken at the same time each day to facilitate treatment compliance. Rabeprazole tablets were taken with or without food in the pivotal clinical trials. A DULTS Treatment of active Gastro-Oesophageal Reflux Disease (GORD): The recommended oral dose for this condition is one 20 mg tablet to be taken once daily for four to eight weeks. Prevention of Relapse of Gastro-oesophageal Reflux Disease (GORD): The recommended oral dose for preventing re Leer el documento completo